Phase II study of a radiotherapy total dose increase in hypoxic lesions identified by F-miso PET/CT in patients with non-small cell lung carcinoma [RTEP5 study].

Fiche publication

Date publication

mars 2017

Journal

Journal of nuclear medicine : official publication, Society of Nuclear Medicine

Auteurs

Membres identifiés du Cancéropôle Est :
Dr MARTIN Etienne , Pr OLIVIER Pierre

Tous les auteurs :
Vera P, Thureau S, Chaumet-Riffaud P, Modzelewski R, Bohn P, Vermandel M, Hapdey S, Pallardy A, Mahé MA, Lacombe M, Boisselier P, Guillemard S, Olivier P, Beckendorf V, Salem N, Charrier N, Chajon E, Devillers A, Aide N, Danhier S, Denis F, Muratet JP, Martin E, Berriolo-Riedinger A, Kolesnikov-Gauthier H, Dansin E, Massabeau C, Courbon F, Farcy-Jacquet MP, Kotzki PO, Houzard C, Mornex F, Vervueren L, Paumier A, Fernandez P, Salaun M, Dubray B

Lien Pubmed

https://www.ncbi.nlm.nih.gov/pubmed/28254869

Résumé

A multicenter phase II study investigated a selective radiotherapy (RT) dose increase to tumor areas with significant F-miso uptake in patients with non-small cell lung carcinoma (NSCLC). Methods: Eligible patients had locally advanced NSCLC, no contra-indication to concomitant chemo-radiotherapy (CCRT). The F-miso uptake on PET/CT was assessed by experts. If there was no uptake, 66 Gy was delivered. In F-miso-positive patients, the contours of the hypoxic area were transferred to the radiation oncologist. It was necessary for the radiotherapy dose to be as high as possible while fulfilling dose-limiting constraints for the spinal cord and lungs. The primary endpoint was tumor response (CR+PR) at 3 months. The secondary endpoints were toxicity, disease-free survival (DFS) and overall survival (OS) at 1 year. The target sample size was set to demonstrate a response rate ≥40% (bilateral α = 0.05, power 1-β = 0.95). Results: Seventy-nine patients were pre-included, 54 were included, and 34 were F-miso positive, 24 of whom received escalated doses of up to 86 Gy. The response rate at 3 months was 31/54 (57%, 95% confidence interval [43%-71%]). DFS and OS at 1 year were 0.86 [0.77 - 0.96] and 0.63 [0.49-0.74], respectively. DFS was longer in the F-miso negative patients (P = 0.004). The RT dose was not associated with DFS when adjusting for the F-miso status. One toxic death (66 Gy) and 1 case of grade 4 pneumonitis (>66 Gy) were reported. Conclusion: Our approach results in a response rate ≥40% with acceptable toxicity. F-miso uptake in NSCLC patients is strongly associated with poor prognosis features that could not be reversed by RT doses up to 86 Gy.